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RECRUITING
NCT04238143
NA

Adipose-Derived Biocellular Regenerative Therapy for Osteoarthritis

Sponsor: Healeon Medical Inc

View on ClinicalTrials.gov

Summary

Use of Biocellular and cellular approaches to treatment of Osteoarthritis (OA), musculoskeletal aging processes, pain, and degenerative changes are to be studied with minimally invasive protocols, and non-pharmaceutical means to relieve OA and its associated issues. Traditional surgical interventions have not yielded convincing long-term outcomes, including total joint replacement surgeries and medical management of the supportive structures. This study is to use a person's own stem/stromal Cells (autologous) plus HD-PRP (important healing growth factors and signal molecules) in such cases of OA for long-term minimally invasive treatments. Baseline (existing) findings are documented, and thence tracked as to progress deemed to be result of the intervention.

Official title: Adipose-Derived Biocellular Regenerative Therapy in Treatment of Osteoarthritis (OA) and Associated Connective Tissue Degeneration and Pain

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2020-01-10

Completion Date

2027-09-30

Last Updated

2024-10-01

Healthy Volunteers

No

Interventions

PROCEDURE

Tissue Stromal Vascular Fraction (tSVF) Arm 1

Harvesting subcutaneous tSVF with sterile, disposable microcannula system

BIOLOGICAL

PRP Concentrate Arm 1

Preparation of PRP Concentrate via sterile Terumo-Harvest System

PROCEDURE

Tissue Stromal Vascular Fraction (tSVF) Arm 2

Harvesting subcutaneous tSVF with sterile, disposable microcannula system

BIOLOGICAL

PRP Concentrate Arm 2

Preparation of PRP Concentrate via sterile Terumo-Harvest System

PROCEDURE

Cellular Stromal Vascular Fraction (cSVF) Arm 2

Isolation-Concentration of cSVF via sterile enzymatic digestion (Liberase TM, Sterile Roche)

PROCEDURE

Cellular Stromal Vascular Fraction (cSVF) Arm 3

Isolation-Concentration of cSVF via sterile enzymatic digestion (Liberase TM, Sterile Roche)

DRUG

Sterile Normal Saline (IV Solution)

Suspension of cSVF in 500 cc Sterile Normal Saline (IV Solution)

Locations (2)

Hemwall Center for Orthopedic Regenerative Medicine

Valencia, California, United States

Regenevita LLC

Stevensville, Montana, United States